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First Meeting of the Subcommittee of the Expert Committee
on the Selection and Use of Essential Medicines

 

Geneva, 9-13 July 2007

 

The First Meeting of the Subcommittee of the Expert Committee on the Selection and Use of Essential Medicines will be held in Geneva from 9 to 13 July 2007. Applications for inclusion, change or deletion of a medicine in the Model List of Essential Medicines for Children had to be sent to the Secretary of the Subcommittee whose address is below before 15 May 2007.

 

The Secretary of the First Meeting of the Subcommittee of the Expert Committee on the Selection and Use of Essential Medicines

Policy, Access and Rational Use

Department of Medicines Policy and Standards

World Health Organization

20 Avenue Appia

CH-1211 Geneva 27

Switzerland
 

Public comments, including letters of support on the applications may be submitted to: emlsecretariat@who.int.

All comments will also be published on the web.

LATE PAPERS

 

Background information:

Draft agenda for the Open Session (English // French)

 

Draft agenda (English // French)

 

WHA60.20: Better medicines for children

 

EB121.R2: Expert Committee on the Selection and Use of Essential Medicines: establishment of a subcommittee

 

ITEM Prepared by: Comments
     

Criteria for the selection of essential medicines for children

Secretariat

Panel members

WHO

Criteria for the selection of fixed-dose combinations for essential medicines for children
 

Secretariat  

Paediatric age categories for essential medicines for children (DRAFT FOR DISCUSSION)

FIP: David Knoppert (Canada, Michael Reed (US), Sandra Benavides (US),  Joyce Totton (Canada), David Hoff (US),  Brady Moffett (US), Kelley Norris (US),  Regis Vaillancourt (Canada), Robert Aucoin (US),  Mary Worthington (US)

Panel members

Public

WHO

Position paper on off-label use of essential medicines for children

Madlen Gazarian MBBS, MSc(ClinEpi) FRACP, Sydney, Australia

WHO

Preferred dosage forms for essential medicines for children (DRAFT FOR DISCUSSION)

FIP: Regis Vaillancourt (Canada), David Knoppert (Canada), Michael Reed (US), Sandra Benavides (US), Joyce Totton (Canada), David Hoff (US), Brady Moffett (US), Kelley Norris (US)

Panel members

Public

WHO

Report on adherence to medications in children

Secretariat

Panel members

Review of other medicines listed in WHO treatment guidelines for children

Secretariat

WHO

Review of regulatory initiatives designed to improve access to registered paediatric medicines:

   

National Institute of Child Health and Human Development National Institutes of Health, Bethesda, USA

 

Kalle Hoppu, MD PhD Poison Information Centre, Helsinki University Central Hospital, Hospital for Children and Adolescents and Dept. of Clinical Pharmacology, University of Helsinki, Helsinki, Finland

 

Review of the 1st draft of model list for essential medicines for children

Background document:   Core list       Complementary list

Review of paediatric formulations for the 14th WHO Model Essential Medicine List --
Focus on parenteral, inhalational and topical preparations

 

Secretariat

Panel members

Public

Reviewers

WHO

APPLICATIONS

   

Abacavir (scored tablet 300 mg)
(Section 6.4.2.1. Nucleoside/Nucleotide reverse transcriptase inhibitors)

GlaxoSmithKline (GSK)

Public
Reviewer
WHO

Antifungal medicines

Secretariat

WHO

Artemether
(20 mg/ml for intramuscular administration)
(Section 6.5.3.1. Antimalarial medicines, for curative treatment)

Dr F.H. Jansen, Medical and R&D Director, Dafra Pharma nv, Slachthuisstraat 30 bus 7, B-2300 Turnhout, Belgium

Public
Reviewer

Artemether + lumefantrine (paediatric powder for oral liquid)
(Section 6.5.3.1. Antimalarial medicines, for curative treatment)

Dr F.H. Jansen, Medical and R&D Director, Dafra Pharma nv, Slachthuisstraat 30 bus 7, B-2300 Turnhout, Belgium

Reviewers
WHO

Artesunate  (Rectal capsules containing  50 mg and 200 mg sodium artesunate)
(Section 6.5.3 - Antimalarial medicines)

Letter re legal status of above-mentioned rectal application forms

Dr P. Olumese, Global Malaria Programme

Reviewers

Artesunate + amodiaquine fixed-dose combination 
(25 mg/ 67.5 mg, 50 mg/ 135 mg and 100 mg/270 mg)
(Section 6.5.3.1. Antimalarial medicines, for curative treatment)

References:

SANOFI-AVENTIS

Reviewer
WHO
Artesunate + mefloquine fixed-dose combination
(Artequin™ Paediatric Stickpacks containing 50 mg artesunate + 125 mg mefloquine each)
(Section 6.5.3.1. Antimalarial medicines, for curative treatment)
Clinical summary // Clinical overview

 
Dieter Meppiel, International Product Manager Malaria, Mepha Ltd., CH-4147 Aesch WHO

Lamivudine (scored tablet 150 mg)
(Section 6.4.2.1. Antiretrovirals, Nucleoside/Nucleotide reverse transcriptase inhibitors)

GlaxoSmithKline (GSK)

Public
Reviewer
WHO
Lamivudine + stavudine + nevirapine fixed-dose combination
40 mg + 10 mg + 70 mg (tablet for oral liquid)
20 mg + 5 mg + 35 mg (tablet for oral liquid)
(Section 6.4.2. Antiretrovirals, fixed-dose combinations)
Ranbaxy Laboratories Limited, India WHO

Lamivudine + zidovudine + nevirapine fixed-dose combination
(tablet for oral liquid: 30 mg + 60 mg + 60 mg)
(Section 6.4.2. Antiretrovirals, fixed-dose combinations)

Ranbaxy Laboratories Limited, India

Reviewer
WHO
Racecadotril

Children of 3 months to 2 years of age: 16 sachets of 1 g powder containing 10 mg of racecadotril Children of 2 years to 15 years of age (approx.) : 16 or 30 sachets of 3 g powder containing 30 mg of racecadotril

Jean-Guillaume Lecomte, Bioprojet Pharma, France Reviewers
WHO

Respiratory tract infections, especially in children with HIV

Secretariat WHO

Review of chloramphenicol injection

Secretariat

Public
WHO

Subcutaneous immunoglobulin  //  Covering letter
(Section 11.2: Plasma fractions for specific use)

Appendix A: Clinical study  //  Appendix  B: Patients’ views on subcutaneous IgG (SCIG) Home Therapy  //  Appendix C: Safety //  Appendix D: Effectiveness  // Appendix E: Cost-effectiveness  // Appendix F: Further experience with subcutaneous immunoglobulin therapy in children with primary immune deficiencies
International availability // EMEA: Core SPC for human normal immunoglobulin for subcutaneous and intramuscular use
Formulary text

International Union of Immunological Societies [IUIS]

Public
Reviewer

Update on oral rehydration solution constituents

JAMA article: Symptomatic Hyponatremia During Treatment of Dehydrating Diarrheal Disease With Reduced Osmolarity Oral Rehydration Solution

Secretariat  

Zidovudine/lamivudine fixed-dose combination
AZT/3TC (scored tablet 300/150 mg)
(Section 6.4.2. Antiretrovirals, fixed-dose combinations)

GlaxoSmithKline (GSK)

Public
WHO
 

 

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Last update:01-Feb-2008